Biomechanical Properties of the Lumbar Paravertebral Muscles

NCT05503758 | Completed

• 1 other identifier: Lumbar Paravertebral muscles
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean delivery (CD) is an obstetric surgery for fetal delivery that involves both an abdominal incision (laparotomy) and a uterine incision (hysterotomy). It is presently the most prevalent surgery in the United States, with over 1 million women giving birth by cesarean section each year.

Conditions

Lumbar Paravertebral Muscles

Outcome Measures

Primary Outcomes (2)

• Lumbar paravertebral muscle frequency (tone)

  Tone is a contractile property of a muscle which describes the resting muscle's resistance to passive and active stretch forces

  Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device

• Lumbar paravertebral muscle stiffness

  Stiffness is a biomechanical property of a muscle and its connective tissue which refers to the tissue's resistance toward the deformation of external load

  Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device

Study Arms (4)

Group A

9 participants have exposed to midline epidural anaesthesia for cesarean delivery.

Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Group B

22 participants have exposed to midline spinal anaesthesia for cesarean delivery.

Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Group C

10 participants underwent general anesthesia for cesarean delivery.

Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Group D

22 participants were in the control group (no previous pregnancy or anaesthesia).

Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Interventions

Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia) DEVICE

The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).

Also known as: Myotonometry

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Because this study is presented to the department of Physical Therapy for Women's Health to observe the changes after cesarean delivery and its relevant anaesthesia.
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Sixty-three women participated in this study and were recruited from South Valley University Teaching Hospitals, in Qena governorate, Egypt.

You may qualify if:

• All women gave birth through a cesarean delivery.
• All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.
• Their ages ranged from 18 to 35 years.
• All participants had a body mass index (BMI) of not more than 30, and a waist-to-hip ratio of not more than 1.
• Participants were assessed between the 6th week to the 12th week postnatal.
• All participants were able to continue all assessment procedures.
• They were medically stable.

You may not qualify if:

• Women who delivered through vaginal delivery.
• Women who delivered through cesarean delivery, but the used anaesthetic technique was the paramedian approach for either the epidural or spinal anaesthesia.
• Women with urinary tract infections.
• Women who were below 18 years old or above 35 years old.
• Women who had a (BMI) above 30 or a waist-to-hip ratio above 1.
• Women who did not continue all assessment procedures.
• Women who had any specific low back pain as women who were diagnosed with lumbar disc prolapse, scoliosis, or spondylolisthesis.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Faculty of physical therapy, South Valley University

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (9)

• Iddrisu M, Khan ZH. Anesthesia for cesarean delivery: general or regional anesthesia-a systematic review. Ain-Shams Journal of Anesthesiology. 2021 Dec;13(1):1-7.

  BACKGROUND

• Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.

  PMID: 30985305 BACKGROUND

• Lenhardt R. Body temperature regulation and anesthesia. Handb Clin Neurol. 2018;157:635-644. doi: 10.1016/B978-0-444-64074-1.00037-9.

  PMID: 30459029 BACKGROUND

• Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.

  PMID: 34721664 BACKGROUND

• Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.

  PMID: 28005829 BACKGROUND

• Sung, S., and Mahdy, H. (2021):

  BACKGROUND

• Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.

  PMID: 31151377 BACKGROUND

• Hamilton RI, Garden CLP, Brown SJ. Immediate effect of a spinal mobilisation intervention on muscle stiffness, tone and elasticity in subjects with lower back pain - A randomized cross-over trial. J Bodyw Mov Ther. 2022 Jan;29:60-67. doi: 10.1016/j.jbmt.2021.09.032. Epub 2021 Oct 9.

  PMID: 35248290 BACKGROUND

• Lo WLA, Yu Q, Mao Y, Li W, Hu C, Li L. Lumbar muscles biomechanical characteristics in young people with chronic spinal pain. BMC Musculoskelet Disord. 2019 Nov 23;20(1):559. doi: 10.1186/s12891-019-2935-z.

  PMID: 31759390 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Physical Therapy for Women's Health

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 17, 2022
• Study Start: June 28, 2021
• Primary Completion: January 29, 2022
• Study Completion: January 29, 2022
• Last Updated: October 2, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)